Act as a key contributor for the preparation of responses to queries from FDA and review content.

Drive the US FDA submission of all asset related documents such as IND/NDA annual reports.

Work with vendor to ensure that regulatory submissions are done in a timely manner

Skills Required

• Understanding of scientific content and complexities.
• Solid knowledge of US regulations, laws, and guidelines. US Regulatory experience a required.
• Good interpersonal skills; willingness to leverage strengths of the team, coordinate with outsourcing partner and peers within Mature Products Strategy and in a cross-functional environment.
• Ability to communicate issues and risks clearly in written and verbal format to teams and management.